The Effects of a Nature-Based Mindfulness-Compassion Intervention for Older Adults Delivered Using Virtual Reality

NCT05531513 | Completed

• 1 other identifier: McGill University
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

The global population is aging at an unprecedented rate, increasing the necessity for effective interventions targeting the mental health needs of older adults. Virtual reality (VR) is a type of technology with the potential to improve mental health and well-being that allows users, via electronic devices such as headsets or goggles, to interact within simulated environments. VR programs using nature, mindfulness-meditation, and compassion may be more immersive and engaging, with research showing that these programs are effective at improving mental health and well-being outcomes in younger adults. However, evidence in this area for older adults is currently lacking. The present project intends to pilot and examine a multi-user 360-High Definition (HD) video VR application, called "Toujours Dimanche", developed in partnership with Super Sublime, a Montreal-based not-for-profit company. This VR application aims to support older adults through incorporating elements of nature, mindfulness-meditation, and compassion via a 4-week program of twice weekly, 10 to 20-minute meditation sessions, for a total of 8 sessions. Thus, this study seeks to pilot, revise and iteratively evaluate, via randomized control trial (RCT) methodology, the acceptability, feasibility, and effectiveness of a multi-user 360-HD video VR application (Toujours Dimanche) at improving older adult mental health and well-being. It is hypothesized that engagement with the 4-week VR-Meditation intervention will lead to lower scores on stress and negative affect and improved scores on well-being, positive affect, and mindfulness, in addition to increased scores on coping self-efficacy, connection with nature, embodied mindfulness, and self-compassion, over time and as compared to the active control group (who will receive psycho-educational pamphlets 1x/week for 4 weeks).

Conditions

Mental Health Wellness 1; Healthy Aging

Keywords

virtual reality; nature; mindfulness; compassion; Gerontechnology; well-being; mental health; older adults

Outcome Measures

Primary Outcomes (4)

• Change from Baseline in Scores on the Perceived Stress Scale (PSS)

  PSS is a 14-item scale used to measure the degree to which life events are experienced and appraised as stressful. It asks respondents how often they have felt certain ways in the past month, with responses ranging from 0 (never) to 4 (very often). English and French versions available.

  At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9)

• Change from Baseline in Scores on the Scale of Positive and Negative Experience (SPANE)

  SPANE is a 12-item questionnaire with six items to assess positive feelings and six items to assess negative feelings. Participants are asked to rate their levels of affect using a 5-point scale ranging from 1 (rarely or never) to 5 (very often or always). English and French versions available.

  At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9)

• Change from Baseline in Scores on the Flourishing Scale (FS)

  The FS is a brief 8-item measure assessing participants' self-perceived success (e.g., purpose, self-esteem, relationships, optimism) and provides a single psychological well-being score. Participants are asked to rate their levels of well-being on a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). English and French versions available.

  At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9)

• Change from Baseline in Scores on the General Self-Efficacy Scale (GSE)

  The GSE is a 10-item scale that measures an individual's confidence in their ability to effectively cope with life challenges. Participants are asked to rate statements on a 4-point scale ranging from 1 (not at all true) to 4 (exactly true). English and French versions available.

  At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9)

Secondary Outcomes (4)

• Change from Baseline in Scores on the Five Facet Mindfulness Questionnaire-Short Form (FFMQ-24)

  At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9)

• Change from Baseline in Scores on the Connectedness to Nature Scale (CNS)

  At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9)

• Change from Baseline in Scores on the Embodied Mindfulness Questionnaire (EMQ)

  At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9)

• Change from Baseline in Scores on the Self-Compassion Questionnaire-Self (CQS)

  At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9)

Other Outcomes (2)

• Change from Time 1 in Scores on the Simulator Sickness Questionnaire (SSQ)

  After the first VR Meditation session at time 1 (week 2), mid-point (week 3), and post-intervention (week 5)

• Researcher Developed Virtual Reality Program Satisfaction Questionnaire

  Post-intervention (week 5)

Study Arms (2)

Virtual Reality (VR) Meditation

EXPERIMENTAL

The VR Meditation intervention will be administered in Arm 1.

Behavioral: Virtual Reality (VR) Meditation

Psychoeducational Pamphlets

ACTIVE COMPARATOR

The Psychoeducation Pamphlet intervention will be administered in Arm 2.

Behavioral: Psychoeducational Pamphlet

Interventions

Virtual Reality (VR) Meditation BEHAVIORAL

The VR-Meditation intervention comprises an evidence-based 360-degree high-definition video VR application incorporating elements of nature, mindfulness and compassion. The VR-Meditation intervention is 4 weeks long and includes includes 4 different themes during the course of the program. Each week will focus on a distinct theme and will consist of two 20-minute VR sessions starting with a 10-minute guided meditation related to the weekly theme (one new meditation per week), followed by 10 minutes of open exploration of the virtual environment, for a total of 8 distinct sessions. The weekly themes are as follows: * Week 1 - Mindfulness of the Environment * Week 2 - Embodied Mindfulness * Week 3 - Embodied and Embedded Compassion * Week 4 - Mindfulness, Compassion, and the External Environment In addition to baseline measures, participants in the VR Meditation condition will be asked to complete measures at mid-point (week 3), post-intervention (week 5), and follow-up (week 9).

Also known as: Toujours Dimanche

Virtual Reality (VR) Meditation

Psychoeducational Pamphlet BEHAVIORAL

The Psychoeducational Pamphlet intervention is 4 weeks long. Participants receive 1 pamphlet per week for a total of 4 different pamphlets. Handouts will provide information about managing stress and enhancing well-being, without referencing nature, mindfulness or compassion (e.g., eating habits, sleep hygiene, relaxation training, art exercises). The handouts will be based on empirical findings and will be written in accessible language with visual charts and specific practices to facilitate their implementation by participants. At the end of the study (i.e., after follow-up), Psychoeducation Pamphlet participants will receive access to the VR-Meditation program. In addition to baseline measures, participants in the Psycho-educational Pamphlet condition will be asked to complete measures at mid-point (week 3), post-intervention (week 5), and follow-up (week 9).

Psychoeducational Pamphlets

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must reside at a Résidence Enharmonie private residence for autonomous older adults in the Montreal, Quebec region
• Must be 60 years of age or older
• Ability to speak English or French

You may not qualify if:

• History of recurrent migraines/seizures/Traumatic Brain Injury during the past year
• Glaucoma or recovery phase of any eye surgery
• Diagnosed epilepsy or severe vertigo

Sponsors & Collaborators

• McGill University: lead
• Super Sublime | Super Splendide: collaborator
• Résidences Enharmonie: collaborator

Study Sites (2)

Piero Corti Residence

Montreal, Quebec, H1W1B2, Canada

Location

Résidences Enharmonie - Résidence Alfredo-Gagliardi

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Meditation

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Bassam Khoury, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to baseline assessment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: After providing consent, potential participants will complete an initial screening with the demographic intake form. Participants who do not meet inclusion or exclusion criteria will be informed that they will be unable to participate in the current study. Participants who meet study criteria will then be asked to complete the baseline survey containing the battery of outcome measures. Upon completion of the baseline measures, participants will be randomly assigned to one of two conditions: the experimental (Virtual Reality) condition or the active control (Psychoeducational Pamphlet) condition. Randomization will occur using a computerized random number generator following a matched random assignment via block procedure. An individual at arm's length (not involved with the intervention, assessment, or analysis) will perform the randomization. Control group participants will be allowed access to the virtual reality program after follow-up data collection is completed (after Week 9).

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 8, 2022
• Study Start: July 21, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

CA (2)